Detecting an analyte in a body fluid

ABSTRACT

A medical device for detecting at least one analyte in a body fluid is disclosed. The medical device comprises:at least one analyte sensor having an insertable portion adapted for at least partially being inserted into a body tissue of a user,at least one insertion cannula, wherein the analyte sensor at least partially is placed inside the insertion cannula;at least one housing, wherein the housing comprises at least one sensor compartment, wherein the sensor compartment forms a sealed compartment receiving at least the insertable portion of the analyte sensor, wherein the sealed compartment comprises at least one detachable upper cap and at least one detachable lower cap, wherein the detachable lower cap is configured for detachment before insertion, thereby opening the insertable portion for insertion, wherein the insertion cannula is attached to the detachable upper cap, wherein the detachable upper cap is configured for detachment after insertion, thereby removing the insertion cannula; andat least one electronics unit, wherein the analyte sensor is operably connected to the electronics unit, wherein the electronics unit comprises at least one interconnect device with at least one electronic component attached thereto, wherein the interconnect device fully or partially surrounds the housing.

FIELD OF THE INVENTION

The invention relates to a medical device for detecting at least oneanalyte in a body fluid, a method for assembling a medical device and amethod of using a medical device. The device and methods according tothe present invention may mainly be used for long-term monitoring of ananalyte concertation in a body fluid, such as for long-term monitoringof a blood glucose level or of the concentration of one or more othertypes of analytes in a body fluid. The invention may both be applied inthe field of home care as well as in the field of professional care,such as in hospitals. Other applications are feasible.

RELATED ART

Monitoring certain body functions, more particularly monitoring one ormore concentrations of certain analytes, plays an important role in theprevention and treatment of various diseases. Without restrictingfurther possible applications, the invention will be described in thefollowing text with reference to blood-glucose monitoring. However,additionally or alternatively, the invention can also be applied toother types of analytes.

Blood glucose monitoring, besides by using optical measurements,specifically may be performed by using electrochemical biosensors.Examples of electrochemical biosensors for measuring glucose,specifically in blood or other body fluids, are known from U.S. Pat.Nos. 5,413,690 A, 5,762,770 A, 5,798,031 A, 6,129,823 A or US2005/0013731 A1.

In addition to so-called spot measurements, in which a sample of abodily fluid is taken from a user in a targeted fashion and examinedwith respect to the analyte concentration, continuous measurements areincreasingly becoming established. Thus, in the recent past, continuousmeasuring of glucose in the interstitial tissue (also referred to ascontinuous monitoring, CM) for example has been established as anotherimportant method for managing, monitoring and controlling a diabetesstate.

In the process, the active sensor region is applied directly to themeasurement site, which is generally arranged in the interstitialtissue, and, for example, converts glucose into electrical charge byusing an enzyme (e.g. glucose oxidase, GOD), which charge is related tothe glucose concentration and can be used as a measurement variable.Examples of such transcutaneous measurement systems are described inU.S. Pat. No. 6,360,888 B1 or in US 2008/0242962 A1.

Hence, current continuous monitoring systems typically aretranscutaneous systems or subcutaneous systems, wherein bothexpressions, in the following, will be used equivalently. This meansthat the actual sensor or at least a measuring portion of the sensor isarranged under the skin of the user. However, an evaluation and controlpart of the system (also referred to as a patch) is generally situatedoutside of the body of the user, outside of the human or animal body. Inthe process, the sensor is generally applied using an insertioninstrument, which is likewise described in US 6,360,888 B1 in anexemplary fashion. Other types of insertion instruments are also known.

The sensor typically comprises a substrate, such as a flat substrate,onto which an electrically conductive pattern of electrodes, conductivetraces and contact pads may be applied. In use, the conductive tracestypically are isolated by using one or more electrically insulatingmaterials. The electrically insulating material typically further alsoacts as a protection against humidity and other detrimental substancesand, as an example, may comprise one or more cover layers such asresists.

As outlined above, in transcutaneous systems, a control part istypically required, which may be located outside the body tissue andwhich has to be in communication with the sensor. Typically, thiscommunication is established by providing at least one electricalcontact between the sensor and the control part, which may be apermanent electrical contact or a releasable electrical contact.Examples of electrical contacts for contacting a triangular assembly ofcontact pads are shown e.g. in DE 954712 B. Other techniques forproviding electrical contacts, such as by appropriate spring contacts,are generally known and may be applied.

In order to avoid detrimental effects of the aggressive environment ontothe conductive properties of the electrical contact, the region of theelectrical contact is typically encapsulated and protected againsthumidity. Generally, encapsulations of electrical locks and contacts byusing appropriate seals is known from e.g. DE 200 20 566 U1.Specifically in transcutaneous or subcutaneous sensors, in which theregion of electrical contact between the sensor and the control part isclose to the human skin, an efficient protection against humidity, dirt,sweat and detergents, such as detergents used for body care, is crucial.

US2012/0197222 A1 discloses medical device inserters and processes ofinserting and using medical devices. A method is disclosed whichcomprises removing a substantially cylindrical cap from an inserter toexpose a substantially cylindrical sleeve; removing a cover from asubstantially cylindrical container holding sensor components; andfitting the sensor components into the inserter.

WO 2010/091028 A1 discloses an integrated analyte monitoring deviceassembly. The integrated analyte monitoring device assembly comprises ananalyte sensor for transcutaneous positioning through a skin layer andmaintained in fluid contact with an interstitial fluid under the skinlayer during a predetermined time period. The analyte sensor has aproximal portion and a distal portion. Sensor electronics are coupled tothe analyte sensor. The sensor electronics comprises a circuit boardhaving a conductive layer and a sensor antenna disposed on theconductive layer. Further, the sensor electronics comprises one or moreelectrical contacts provided on the circuit board and coupled with theproximal portion of the analyte sensor to maintain continuous electricalcommunication. Further, the sensor electronics comprises: a dataprocessing component provided on the circuit board and in signalcommunication with the analyte sensor. The data processing component isconfigured to execute one or more routines for processing signalsreceived from the analyte sensor. Further, the data processing componentis configured to control the transmission of data associated with theprocessed signals received from the analyte sensor to a remote locationusing the sensor antenna in response to a request signal received fromthe remote location.

WO 2014/018928 A1 discloses on-body analyte monitoring devicesconfigured for uncompressed and compressed configurations and methods ofusing the analyte monitoring devices. The devices comprise a collapsiblehousing, wherein upon desired placement and user application of force tothe housing converts the analyte monitoring device from an uncompressedconfiguration to a low-profile compressed state while guiding an analytesensor through the skin and into contact with bodily fluid to measure ananalyte level therein. Also provided are systems and kits.

European patent application number 14 180 045.8, filed on Aug. 6, 2014,discloses a medical device and a method for producing a medical device.The medical device comprises at least one implantable device having atleast one implantable portion adapted for at least partially beingimplanted into a body tissue of a user. The implantable device furtherhas at least one contact portion connected to the implantable portion.The medical device further comprises at least one housing. The housingis configured to receive the implantable portion. The housing isconfigured to provide a sterile packaging such that the implantableportion is sealed against a surrounding environment. The housingcomprises at least one first part and at least one second part. Thefirst part and the second part are removable connectable to form thesterile packaging. The first part comprises at least one first sealingsurface and the second part comprises at least one second sealingsurface. The first sealing surface and the second sealing surfaceinteract to form a sealing area. The implantable device has aninterconnecting portion connecting the implantable portion and thecontact portion. The interconnecting portion is led through the sealingarea.

Despite the advantages and the progress achieved by the above-mentioneddevelopments, specifically in the field of continuous monitoringtechnology, some significant technical challenges remain. Thus,generally, known techniques for protecting an electrical contact betweena sensor and a control part generally are rather complex. An assembly ofa plurality of components is generally required, which typically impliesa complex and costly manufacturing process. Further, known techniquesgenerally require voluminous components, which is an issue, specificallyconsidering the fact that miniaturizing the sensor systems is a factorcontributing to the convenience of use.

Specifically in case complex encapsulation parts manufactured by plasticmolding techniques are required for protecting the electrical contacts,a rising of costs and sensor volume typically has to be taken intoaccount. Further, cleaning of complex protective covers, such asprotections including O-rings or other seals, turns out to be difficult.

Problem to be Solved

It is therefore an objective of the present invention to provide amedical device for detecting at least one analyte in a body fluid, amethod for assembling a medical device and a method of using a medicaldevice, which at least partially avoid the shortcomings of known devicesand methods of this kind and which at least partially address theabove-mentioned challenges. Specifically, a device and methods shall bedisclosed which allow for easy manufacturing and simple handlingprocesses by a user.

SUMMARY OF THE INVENTION

This problem is solved by a medical device for detecting at least oneanalyte in a body fluid, a method for assembling a medical device and amethod of using a medical device, having the features of the independentclaims. Preferred embodiments of the invention, which may be realized inan isolated way or in any arbitrary combination, are disclosed in thedependent claims.

As used in the following, the terms “have”, “comprise” or “include” orany arbitrary grammatical variations thereof are used in a non-exclusiveway. Thus, these terms may both refer to a situation in which, besidesthe feature introduced by these terms, no further features are presentin the entity described in this context and to a situation in which oneor more further features are present. As an example, the expressions “Ahas B”, “A comprises B” and “A includes B” may both refer to a situationin which, besides B, no other element is present in A (i.e. a situationin which A solely and exclusively consists of B) and to a situation inwhich, besides B, one or more further elements are present in entity A,such as element C, elements C and D or even further elements.

Further, it shall be noted that the terms “at least one”, “one or more”or similar expressions indicating that a feature or element may bepresent once or more than once typically will be used only once whenintroducing the respective feature or element. In the following, in mostcases, when referring to the respective feature or element, theexpressions “at least one” or “one or more” will not be repeated,non-withstanding the fact that the respective feature or element may bepresent once or more than once.

Further, as used in the following, the terms “preferably”, “morepreferably”, “particularly”, “more particularly”, “specifically”, “morespecifically” or similar terms are used in conjunction with optionalfeatures, without restricting alternative possibilities. Thus, featuresintroduced by these terms are optional features and are not intended torestrict the scope of the claims in any way. The invention may, as theskilled person will recognize, be performed by using alternativefeatures. Similarly, features introduced by “in an embodiment of theinvention” or similar expressions are intended to be optional features,without any restriction regarding alternative embodiments of theinvention, without any restrictions regarding the scope of the inventionand without any restriction regarding the possibility of combining thefeatures introduced in such way with other optional or non-optionalfeatures of the invention.

In a first aspect of the present invention, a medical device fordetecting at least one analyte in a body fluid is disclosed. The medicaldevice comprises at least one analyte sensor having an insertableportion adapted for at least partially being inserted into a body tissueof a user. The medical device further comprises at least one insertioncannula. The analyte sensor is at least partially placed inside theinsertion cannula. Further, the medical device comprises at least onehousing. The housing comprises at least one sensor compartmentconfigured to at least partially receive the analyte sensor. The sensorcompartment forms a sealed compartment receiving at least the insertableportion of the analyte sensor. The sealed compartment comprises at leastone detachable upper cap and at least one detachable lower cap. Thedetachable lower cap is configured for detachment before insertion,thereby opening the insertable portion for insertion. The insertioncannula is attached to the detachable upper cap. The detachable uppercap is configured for detachment after insertion, thereby removing theinsertion cannula. Further, the medical device comprises at least oneelectronics unit. The analyte sensor is operably connected to theelectronics unit. The electronics unit comprises at least oneinterconnect device with at least one electronic component attachedthereto. The interconnect device fully or partially. i.e. at leastpartially, surrounds the housing.

As generally used within the present invention, the term “medicaldevice” may refer to an arbitrary device configured for conducting atleast one medical analysis and/or at least one medical procedure. Themedical device therefore generally may be an arbitrary device configuredfor performing at least one diagnostic purpose and/or at least onetherapeutic purpose. In the following, without restricting furtherembodiments, the present invention mainly will be described in terms ofa medical device configured for performing at least one diagnosticpurpose and, specifically, a medical device comprising at least oneanalyte sensor for performing at least one analysis. The medical devicespecifically may comprise an assembly of two or more components capableof interacting with each other, such as in order to perform one or morediagnostic and/or therapeutic purposes, such as in order to perform themedical analysis and/or the medical procedure. Specifically, the two ormore components may be capable of performing at least one detection ofthe at least one analyte in the body fluid and/or in order to contributeto the at least one detection of the at least one analyte in the bodyfluid. The medical device generally may also be or may comprise at leastone of a sensor assembly, a sensor system, a sensor kit or a sensordevice.

The medical device may be a disposable medical device. The term“disposable medical device” may generally refer to an arbitrary medicaldevice configured to be disposed of after use. Thus, one or morematerials may specifically be low priced and/or easily recyclable.Specifically, the electronics unit may be a single-use electronics unit.The term “single-use” may generally refer to a property of an arbitraryelement of being configured to be applied only for one time. Thus, afterdetecting the at least one analyte in the body fluid, the user mayremove the electronics units from the body tissue, dispose theelectronics unit and may utilize a further, new medical devicecomprising a further, new electronics unit for another detection of theanalyte in the body fluid.

As generally used within the present invention, the terms “patient” and“user” may refer to a human being or an animal, independent from thefact that the human being or animal, respectively, may be in a healthycondition or may suffer from one or more diseases. As an example, thepatient or the user may be a human being or an animal suffering fromdiabetes. However, additionally or alternatively, the invention may beapplied to other types of users or patients or diseases.

As further used herein, the term “body fluid” generally may refer to afluid which typically is present in a body or body tissue of the user orthe patient and/or which may be produced by the body of the user or thepatient. As an example for body tissue, interstitial tissue may benamed. Thus, as an example, the body fluid may be selected from thegroup consisting of blood and interstitial fluid. However, additionallyor alternatively, one or more other types of body fluids may be used,such as saliva, tear fluid, urine or other body fluids. During detectionof the at least one analyte, the body fluid may be present within thebody or body tissue. Thus, specifically, as will be outlined in furtherdetail below, the sensor may be configured for detecting at least oneanalyte in a body tissue.

As further used herein, the term “analyte” may refer to an arbitraryelement, component or compound which may be present in the body fluidand the presence and/or the concentration of which may be of interestfor the user, the patient or medical staff such as a medical doctor.Particularly, the analyte may be or may comprise an arbitrary chemicalsubstance or chemical compound which may take part in the metabolism ofthe user or the patient, such as at least one metabolite. As an example,the at least one analyte may be selected from the group consisting ofglucose, cholesterol, triglycerides, lactate. Additionally oralternatively, however, other types of analytes may be used and/or anycombination of analytes may be determined. The detection of the at leastone analyte specifically may be an analyte-specific detection.

As further used herein, the term “detect” generally refers to theprocess of determining the presence and/or the quantity and/or theconcentration of the at least one analyte. Thus, the detection may be ormay comprise a qualitative detection, simply determining the presence ofthe at least one analyte or the absence of the at least one analyte,and/or may be or may comprise a quantitative detection, which determinesthe quantity and/or the concentration of the at least one analyte. As aresult of the detection, at least one signal may be produced whichcharacterizes an outcome of the detection, such as at least onemeasurement signal. The at least one signal specifically may be or maycomprise at least one electronic signal such as at least one voltageand/or at least one current. The at least one signal may be or maycomprise at least one analogue signal and/or may be or may comprise atleast one digital signal. As further used herein, the term “determininga concentration” generally may refer to a process of generating at leastone representative result or a plurality of representative resultsindicating the concentration of the analyte in the body fluid.

As further used herein, the term “analyte sensor” may generally refer toan arbitrary element which is adapted to perform the above-mentionedprocess of the detection and/or which is adapted to be used in theabove-mentioned process of the detection. Thus, the sensor specificallymay be adapted to determine the concentration of the analyte and/or apresence of the analyte.

The analyte sensor specifically may be an electrochemical sensor. Asused herein, an “electrochemical sensor” generally is a sensor which isconfigured to conduct an electrochemical measurement in order to detectthe at least one analyte contained in the body fluid. The term“electrochemical measurement” refers to a detection of anelectrochemically detectable property of the analyte, such as anelectrochemical detection reaction. Thus, for example, theelectrochemical detection reaction may be detected by comparing one ormore electrode potentials. The electrochemical sensor specifically maybe adapted to and/or may be usable to generate at least one electricalsensor signal which directly or indirectly indicates the presence and/orthe extent of the electrochemical detection reaction, such as at leastone current and/or at least one voltage. The detection may beanalyte-specific. The measurement may be a qualitative and/or aquantitative measurement. Still, other embodiments are feasible.

The analyte sensor may particularly be a transcutaneous sensor. As usedherein, the term “transcutaneous sensor” generally refers to anarbitrary sensor which is adapted to be fully or at least partlyarranged within the body tissue of the patient or the user. For thispurpose, the analyte sensor comprises the insertable portion. The term“insertable portion” may generally refer to a part or component of anelement configured to be insertable into an arbitrary body tissue. Inorder to further render the analyte sensor to be usable as atranscutaneous sensor, the analyte sensor may fully or partially providea biocompatible surface, i.e. a surface which, at least during durationsof use, do not have any detrimental effects on the user, the patient orthe body tissue. Specifically, the insertable portion of the analytesensor may have a biocompatible surface. As an example, thetranscutaneous sensor, specifically the insertable portion, may fully orpartially be covered with at least one biocompatible membrane, such asat least one polymer membrane or gel membrane which is permeable for theat least one analyte and/or the at least one body fluid and which, onthe other hand, retains sensor substances such as one or more testchemicals within the sensor and prevents a migration of these substancesinto the body tissue. Other parts or components of the analyte sensormay stay outside of the body tissue. The other parts may be connectableto an evaluation device such as to the electronics units as will furtherbe described below.

The transcutaneous sensor generally may be dimensioned such that atranscutaneous insertion is feasible, such as by providing a width in adirection perpendicular to an insertion direction of no more than 5 mm,preferably of no more than 2 mm, more preferably of no more than 1.5 mm.The sensor may have a length of less than 50 mm, such as a length of 30mm or less, e.g. a length of 5 mm to 30 mm. As used herein, the term“length” may refer to a direction parallel to the insertion direction.It shall be noted, however, that other dimensions are feasible.

The term “insertion cannula” may generally refer to an arbitrary elementwhich may be insertable into the body tissue of the user, particularlyin order to deliver or to transfer a further element. Therefore, theinsertion cannula may specifically be or may comprise a hollow tube or ahollow needle. The insertion cannula e.g. may comprise at least onecross-section selected from the group consisting of: round, elliptical,U-shaped, V-shaped. Still, other embodiments are feasible. Specifically,the insertion cannula may be a slotted cannula. The insertion cannulamay be configured to be inserted vertically or at an angle of 90° to 30°to the body tissue of the user.

The medical device may further comprise at least one septum received inthe sensor compartment. As generally used herein, the term “septum” maygenerally refer to an arbitrary sealing element configured for sealingof a volume or room providing an environmental protection againstmoisture and/or an ambient atmosphere, or the like. As an example, theseptum may be or may comprise at least one pierceable foil, disk, shim,plug or plate, made of a material which may be pierced by the insertioncannula and which may re-seal a piercing hole generated by the insertioncannula after retraction of the insertion cannula. Specifically, theseptum may be made of an elastic material such as an elastomer. Theseptum may be manufactured by injection molding, specifically bytwo-component injection molding. The septum may be penetrable by anelongate object with a small diameter such as by the insertion cannula.After a penetration by the elongate object, an opening of the septumcaused by the elongate object may be closed itself and the septum mayfurther be configured to provide a tight sealing from the environment ofthe volume or the room. Specifically, the septum may be configured forsealing a remainder of the sensor compartment after detachment of thedetachable upper cap. The insertion cannula may be configured for beingpulled through the septum when the detachable upper cap is detached fromthe housing.

Further, the insertion cannula may comprise at least one barbed hookconfigured to prevent a further movement of the insertion cannula afterusage. As further used herein, the term “barbed hook” may refer to anarbitrary tool which may comprise a portion which is curved or indentedsuch that the portion may be applied to hold another object. Moreover,the barbed hook may be shaped in a specific manner such that a passingof the other object through the barbed hook may only be possible in onedirection, wherein, in the counter direction, a movement may becompletely suppressed or at least to a large extent reduced.Specifically, this property may be realized by small, further hooksbeing located such that ends of the hooks may point in a directionopposing a direction in which the other object is movable.

The medical device may further comprise at least one retractionmechanism for retracting the insertion cannula after insertion of theinsertable portion of the analyte sensor into the body tissue.

The term “retraction mechanism” may generally refer to an arbitraryconstruction which is configured to move an object in an oppositedirection of a direction in which the object may have been moved beforethe retraction mechanism is applied. Therefore, the retraction mechanismmay comprise at least one retraction spring element, more preferably atleast one retraction spring element disposed between the housing and theinsertion cannula and biased in order to retract the insertion cannulafrom the body tissue. The retraction mechanism may at least partially becomprised within the detachable upper cap.

As used herein, the term “electronics unit” generally refers to anarbitrary device having at least one electronic component. Specifically,the electronics unit may comprise at least one electronic component forone or more of performing a measurement with the analyte sensor,performing a voltage measurement, performing a current measurement,recording sensor signals, storing measurement signals or measurementdata, transmitting sensor signals or measurement data to another device.The electronics unit may specifically be embodied as a transmitter ormay comprise a transmitter, for transmitting data. Other embodiments ofthe electronic components are feasible.

The electronics unit comprises at least one interconnect device,preferably a printed circuit board, more preferably a flexible printedcircuit board. As used herein, an interconnect device generally refersto an element or a combination of elements which are capable of carryingone or more electronics components and interconnecting these one or moreelectronics components, such as interconnecting the one or moreelectronics components electrically or electronically with each otherand/or with one or more contact pads. As an example, the interconnectdevice may comprise a base and one or more electrical traces and/or oneor more electrical contact pads disposed thereon and/or therein. As anexample, the interconnect device may comprise a printed circuit boardwhich may either be rigid or fully or partially be embodied as aflexible printed circuit board. The base, as an example, may be a flatelement having a lateral extension which exceeds its width by at least afactor of 10, more preferably by at least a factor of 100 or even afactor of 1000. Other embodiments are feasible. Rigid materials whichmay be used for the base are fiber-enforced plastic materials such asfiber-enforced epoxy materials like glass-fiber-enforced epoxy materialssuch as FR-4. Other materials may be used. Specifically, as outlinedabove, the base may be a flexible base, such that the interconnectingdevice may fully or partially be embodied as a flexible printed circuitboard. In this case, as an example, the flexible base may fully orpartially be made of one or more flexible plastic materials such as oneor more plastic foils or laminate, such as polyimides.

As outlined above, the electronics unit comprises at least oneelectronic component attached to the interconnect device. Therein, theat least one electronic component may directly or indirectly be attachedto the interconnect device. As an example, the electronic component maydirectly be attached to the interconnect device by using one or more ofsoldering, bonding or electrically conductive adhesive. Thus, theinterconnect device may comprise one or more contact pads, whereincorresponding contacts of the electronic component are electricallyconnected to the one or more contact pads. Additionally oralternatively, however, the at least one electronic component mayindirectly be attached to the interconnect device, such as via at leastone electronic housing. Thus, the at least one electronic housing may beattached to the interconnect device. Still, an electrical contactbetween the at least one electronic component and the interconnectdevice may be made, such as via at least one contact passing through theelectronic housing. The electronic housing may fully or partiallysurround the at least one electronic component. As an example, theelectronic housing may comprise at least one lower electronic housingcomponent attached to the interconnect device, wherein the at least oneelectronic devices inserted into the lower electronic housing componenton a side opposing the interconnect device. The at least one electronichousing may further comprise at least one further electronic housingcomponent, such as at least one upper electronic housing component,which, in conjunction with the lower electronic housing component, mayform an encapsulation which fully or partially surrounds the electroniccomponent. Additionally or alternatively, however, other types ofencapsulation of the at least one electronic component may be used, suchas encapsulation by using one or more casting and/or potting compounds.Thus, as an example, the lower electronic housing component may be usedfor receiving the at least one electronic component, wherein the uppershell or protection above the electronic component is created by using acasting and/or potting, such as by using one or more of an epoxy, athermoplastic polymer, a rather, a silicone, and epoxies or the like.Additionally or alternatively, no electronic housing component may beused at all, such as by directly placing the at least one electroniccomponent onto the interconnect device.

Similarly, the at least one optional energy reservoir, such as at the atleast one battery, may directly or indirectly be attached to the atleast one interconnect device. Thus, again, the at least one energyreservoir may fully or partially be encapsulated by at least one energyreservoir housing. Again, the at least one energy reservoir housing maycomprise one or more components, such as a lower energy reservoirhousing component placed onto the interconnect device, configured forreceiving the at least one energy reservoir. As an upper protection,either an upper energy reservoir housing such as an upper cover may beused or, additionally or alternatively, a casting or potting. In bothcases, the energy reservoir may electrically be connected via the atleast one interconnect device with the at least one electroniccomponent. Thus, generally, in this embodiment or other embodiments, theat least one interconnect device may comprise one or more electricaltraces for electrically connecting the optional energy reservoir withthe at least one electronic component, directly or indirectly.

As further used herein, the term “electronic component” generally refersto an arbitrary element or combination of elements which fulfill atleast one electrical or electronic purpose. Specifically, the at leastone electronic component may be or may comprise at least one componentselected from the group consisting of an integrated circuit, anamplifier, a resistor, a transistor, a capacitor, a diode or anarbitrary combination thereof. The at least one electronic componentspecifically may be or may comprise at least one device capable ofcontrolling the analyte sensor, in order to perform at least oneanalytical measurement with the analyte sensor. Specifically, the atleast one device may comprise at least one voltage measurement deviceand/or at least one current measurement device. Other setups orembodiments are feasible. The at least one electronic component, as anexample, may comprise at least one application-specific integratedcircuit (ASIC).

As described above, the analyte sensor is operably connected to theelectronics unit. The term “operably connected” may specifically referto a state, wherein two or more objects are connected to each other suchthat they can interact with each other. Specifically, the analyte sensormay be operably connected to the electronics unit such that sensorsignals of the analyte sensor may be transmitted to the electronicsunit. Thus, the term “operably connected” may also refer to anelectrically conductive connection. The analyte sensor may beelectrically connected to the interconnect device, preferably via atleast one of a soldering connection, a welding connection, an electricalbonding, a conductive adhesive material or a plug connection. Theinterconnect device may be fixedly positioned within the electronicscompartment of the housing.

As generally used herein, the term “housing” may generally refer to anarbitrary element which is adapted to fully or partially surround and/orreceive one or more elements in order to provide one or more of amechanical protection, a mechanical stability, an environmentalprotection against moisture and/or ambient atmosphere, a shieldingagainst electromagnetic influences or the like. Thus, the housing maysimply provide a basis for attachment and/or holding one or more furthercomponents or elements. Additionally or alternatively, the housing mayprovide one or more interior spaces for receiving one or more furthercomponents or elements. The housing may specifically be manufactured byinjection molding. However, other embodiments are feasible.

As used herein, the term “compartment” may generally refer to anarbitrary subpart of a superior element creating a partially or fullyenclosed space that may be usable to contain and/or store objects. Thesubpart may specifically be completely or at least to a large extendclosed such that an interior of the compartment may be isolated from asurrounding environment. Exemplarily, the compartment may be separatedfrom other parts of the superior element by one or more walls. Thus,within the housing, two or more compartments may be comprised which mayfully or partially be separated from one another by one or more walls ofthe housing. Each compartment may comprise a continuous space or lumenconfigured for receiving one or more objects. The housing, however, mayalso fully or partially be embodied by using one or more deformablematerials, in a deformable state and/or in a hardened or a cured state.

As described above, the sensor compartment forms a sealed compartment.The term “sealed compartment” may refer to a property of a compartmentof being isolated from a surrounding environment such that a transfer ofgas, fluids and/or solid elements is completely or at least to a largeextent reduced. Specifically, the sensor compartment may be configuredto provide a sterile packaging for the insertable portion of the analytesensor. Exemplarily, the detachable lower cap may be a sterile capconfigured to provide sterile packaging for the insertable portion ofthe analyte sensor, such that the insertable portion is sealed against asurrounding environment. The term “sterile” may generally refer to aproperty of an arbitrary object of being at least to a large extent freefrom all forms of life and/or other biological agents such as prions,viruses, fungi, bacteria or spore forms. Thus, the sterile object may betreated by at least one sterilization process that eliminates and/ordeactivates the forms of life and/or the other biological agents. Thesterilization process may comprise one or more of the followingtechniques: heating, chemical treatment, irradiation, high pressure,filtration. However, other techniques are feasible. The sterilizationprocess may be conducted within a specified region or area of the objectsuch as a surface of the object.

As will be outlined in further detail below, the sensor compartment maycomprise at least one intermediate component. The term “intermediatecomponent” may refer to an arbitrary compartment between at least twoother compartments and/or which may be located in at least one othercompartment. Thus, the intermediate component may be located in thesensor compartment. The upper cap and the lower cap may be attached tothe intermediate component and/or may be attached to each other, in adetachable fashion. The intermediate component may be located in betweenthe upper cap and the lower cap. The interconnect device, as will beoutlined in further detail below, may be attached to the intermediatecomponent or vice versa.

The term “cap” may refer to an arbitrary element which is configured toclose or to seal a volume. Specifically, the cap may close or seal anopening of an arbitrary container. The terms “upper cap” and “lower cap”may be considered as description without specifying an order and withoutexcluding a possibility that several kinds of upper caps and lower capsmay be applied. The term “detachable” may refer to a property of anelement of being removable from an arbitrary object. Thereby, a closebonding or contact between the element and the object may bedisconnected. Generally, the element may be removable in a reversiblemanner wherein the element may be attachable and detachable from theobject or in an irreversible manner wherein the element may not beattachable to the object after detachment. Specifically, as will beoutlined in further detail below, the detachable upper cap and/or thedetachable lower cap may be connected to one another and/or to theintermediate component via at least one predetermined breaking point,such as via at least one predetermined breaking point having a weakeningin the wall of the housing in order to allow for a simple andwell-defined detachment of the caps by hand, such as at least onepredetermined breaking point comprising one or more grooves, notches orslots in the wall. Alternatively, instead of using a predeterminedbreaking point, other types of detachable connections may be used, suchas a screwing connection.

The detachable upper cap and/or the detachable lower cap may exemplarilyhave an elongate shape and provide an interior volume. The detachableupper cap and/or the detachable lower cap may have one or more handlesallowing for a user to detach the respective cap. The detachable uppercap and the detachable lower cap may be detachably connected to theintermediate component. Specifically, the detachable upper cap and thedetachable lower cap may be detachably connected to the intermediatecomponent on opposing sides of the intermediate component.Alternatively, the detachable upper cap and the detachable lower cap maybe detachably connected to one another, with the intermediate componentin between. Specifically, the detachable upper cap may partiallysurround the insertion cannula. The insertion cannula may be fixedlyattached to the detachable upper cap.

As outlined above, the detachable upper cap may be detachably connectedto the intermediate component, such as at at least one upperpredetermined breaking point. Additionally or alternatively, thedetachable lower cap may be detachably connected to the intermediatecomponent at at least one lower predetermined breaking point. As furtherused herein, the term “predetermined breaking point” may refer to anarbitrary part of an element being configured to break during mechanicalload while other parts of the element remain undamaged. Specifically,the predetermined breaking point may comprise at least one notch whereina thickness of the element may be smaller in comparison to other partsof the element. The upper predetermined breaking point and the lowerpredetermined breaking point may specifically be ring-shaped breakingpoints. The terms “upper breaking point” and “lower breaking point” maybe considered as description without specifying an order and withoutexcluding a possibility that several kinds of upper breaking points andlower breaking points may be applied. Additionally or alternatively,instead of using one or more predetermined breaking points, other typesof detachable connections may be used, such as one or more screwingconnections.

The sensor compartment may comprise at least one sealed opening, such asfor leading a portion of the analyte sensor out of the sensorcompartment, in order to be operably connected to the electronics unit,such as to the interconnect device and/or to the at least one electroniccomponent attached thereto. The term “sealed” may generally refer to aproperty of an arbitrary element of being completely or at least to alarge extent isolated from a surrounding environment. The sealed openingmay comprise at least one sealing element. The term “sealing element”may generally refer to an arbitrary element which is configured to coverone or more elements to be sealed off from environmental influences suchas moisture. The sealing element may seal the sensor compartment.Exemplarily, the sealing element may comprise at least one sealing lip.As used herein, the term “sealing lip” may refer to a maximum in across-sectional profile of the sealing element, which, when the sealingelement thereon is pressed on another surface, is the first part of thesealing element to contact the other surface. The profile itself may besymmetric or asymmetric in shape, wherein an asymmetric profile may befavorable. The sealing element may comprise at least one sealingmaterial, particularly a deformable sealing material, more preferably anadhesive material. The analyte sensor may pass through the sealedopening. The analyte sensor may be partially received in the sensorcompartment. Specifically, the insertable portion may be at leastpartially received in the sensor compartment. The at least one sealedopening specifically may fully or partially be part of or fully orpartially be integrated in the intermediate component. Thus, theintermediate component, as an example, may fully or partially be made ofa deformable or flexible material, such as of at least one elastomericmaterial.

The interconnect device generally may have an arbitrary shape. Thus, asoutlined above, the interconnect device specifically may be a flatdevice, having a flat base. The flat base may directly or indirectly beattached to the skin of the user. Thus, as an example, the interconnectdevice may comprise an upper side and a lower side, specifically a flatlower side, wherein the lower side comprises at least one adhesiveelement for attachment of the interconnect device to the skin of theuser. Thus, as an example, at least one adhesive may directly orindirectly be applied to the lower side. Additionally or alternatively,at least one plaster or adhesive strip may be attached directly orindirectly to the lower side, with an adhesive surface facing the skinof the user. The lower side specifically may be a side from which theanalyte sensor protrudes from the medical device.

The cross-section of the interconnect device, such as the cross-sectionof the flat base, however, may be adapted to the handling steps forinsertion. Specifically, the interconnect device, such as the flexibleinterconnect device and more specifically the flexible printed circuitboard, may have a noncircular shape, with one or more portions.Specifically, an asymmetric shape may be used. As an example, theinterconnect device may comprise a first portion, preferably a firstflap, having the electronic component attached thereto, and a secondportion, preferably a second flap, having an electrical energyreservoir, preferably a battery, attached thereto. The first portion orsecond portion, as an example, each may have an essentially circularshape, wherein the circular shape, as an example, may be broken only ina region in which the first or second portion is connected to a centralportion of the interconnect device which may be connected to thehousing. Thus, as an example, the interconnect device may comprise acentral portion connected to the housing and one, two or more than twoportions attached to the central portion. The central portion, as anexample, may comprise an opening through which the housing may penetratethe interconnect device.

Thus, as an example, the interconnect device specifically may compriseone, two or more than two flaps or wings which protrude from thehousing. As an example, the interconnect device may have a shape of thewings of a moth or butterfly, preferably with foldable wings which maybe folded upwardly or downwardly. Thus, as an example, the first portionand the second portion may be foldable, preferably in an upwardly ordownwardly fashion towards an axis of the housing. The foldingspecifically may be used during insertion, in order to provide a morestable grip to the medical device when pushing the insertion cannulainto the body tissue of the user. Thus, as an example, the first andsecond portions may be folded upwardly during insertion, and,afterwards, may be folded into a flat configuration again, such as inorder to be placed flatly against the skin of the user and, preferably,to be adhered to the skin of the user by at least one adhesive.

As outlined above, the interconnect device may have an opening, whereinthe housing fully or partially may penetrate the interconnect devicethrough the opening. Thus, as an example, the housing may partially belocated on an upper side of the interconnect device and partially belocated on a lower side of the interconnect device, such as by partiallyprotruding upwardly from the interconnect device and partiallyprotruding downwardly from the interconnect device. Therein, an upwarddirection may be a direction which faces away from the skin of the userand a downward direction may be a direction which faces the skin of theuser. As outlined above, the insertion cannula may point in the downwarddirection.

As further outlined above, the housing may fully or partially beattached to the interconnect device. Specifically, the housing may beattached to a rim of the opening of the interconnect device. As anexample, the housing may comprise an intermediate component, as outlinedabove, wherein the interconnect device may fully or partially beattached to the intermediate component. Thus, the intermediate componentmay comprise the above-mentioned rim, with the interconnect deviceattached thereto.

The detachable upper cap and the detachable lower cap specifically maybe disposed on opposite sides of the interconnect device. As furtheroutlined above, the housing may have at least one intermediate componentdisposed in between the detachable upper cap and the detachable lowercap. The intermediate component specifically may comprise a sealingring, specifically a sealing ring which seals a connection between theupper cap and the lower cap. The detachable upper cap and the detachablelower cap may be attached to one another, preferably by a screwingmechanism, with the intermediate component located in between thedetachable upper cap and the detachable lower cap.

As outlined above, the analyte sensor, such as with the insertableportion, may be located inside the sensor compartment and, with at leastone other portion, such as with an interconnecting portion, may belocated outside the sensor compartment, in order to be operablyconnected to the electronics unit, such as to the interconnect deviceand/or the at least one electronic component. In order to lead theanalyte sensor out of the sensor compartment in a sealed fashion and inorder to avoid ingression of humidity, dirt or microbial pollution, theintermediate component may comprise at least one sealed opening, whereinthe analyte sensor passes through the sealed opening. The insertableportion of the analyte sensor may at least partially be received in thesensor compartment, wherein an opposing end of the analyte sensor, suchas an interconnecting portion of the analyte sensor, may be attached tothe electronics unit.

The intermediate component, as an example, may be made of a rigidmaterial. Alternatively, however, the intermediate component may fullyor partially be made of a deformable material, such as of a fully orpartially flexible or elastic material. Thus, as an example, the atleast one intermediate component may be made of an elastomeric material.

The interconnect device, as outlined above, may be connectedmechanically to the intermediate component. As an example, theinterconnect device may fully or partially surround the intermediatecomponent. The intermediate component may comprise a protruding rim,wherein the interconnect device may fully or partially be connected,specifically mechanically, to the protruding rim. Generally, formechanically connecting the interconnect device to the housing, such asto the intermediate component, any type of connection mechanism may beused. Specifically, however, the interconnect device may be connected tothe housing by using a gluing or welding connection. Other connections,however, are feasible, such as form-fit or force-fit connections.

The insertion cannula specifically may fixedly be attached to thedetachable upper cap. The medical device may further comprise at leastone septum received in the sensor compartment, wherein the insertioncannula passes through the septum, wherein the septum is con-figured forsealing a remainder of the sensor compartment after detachment of thedetachable upper cap.

The electronics unit may contain one or more electronic componentsattached to the interconnect device. The electronic componentspecifically may be configured for controlling a measurement performedwith the analyte sensor. The medical electronic component specificallymay contain an application-specific integrated circuit (ASIC). Theelectronic component specifically may contain at least one of ameasurement device configured for performing an electrochemicalmeasurement with the analyte sensor, such as at least one currentmeasurement device and/or at least one voltage measurement device.Further, one or more of a current source and/or a voltage source may becomprised.

The detachable upper cap and/or the detachable upper cap may comprise atleast one handle. As further used herein, the term “handle” may refer toan arbitrary element which may be part of an object that can be moved orused by hand. Specifically, the detachable lower cap may comprise thehandle configured for enabling the user to detach the detachable lowercap from the medical device. The handle may comprise at least onehygroscopic material, preferably at least one desiccant, more preferablyactivated carbon.

The medical device may further comprise at least one insertion aidconfigured for enabling a user to drive the insertion cannula into thebody tissue and to insert the insertable portion of the analyte sensor.As further used herein, the term “insertion aid” may refer to anarbitrary technical construction being configured to insert an objectinto another object. Therefore, the insertion aid may comprise at leastone insertion mechanism. As further used herein, the term “mechanism”may refer to an arbitrary mechanism designed to transform input forcesand movement into a desired set of output forces and movement.Specifically, the insertion mechanism may be configured such that theuser may apply a force in a direction of insertion to the insertioncannula. Therefore, the insertion aid may be configured to facilitate ahandling of the medical device by the user and/or to reduce applicationerrors. The insertion aid may at least partially surround the housing.Further, the insertion aid may be at least partially coupled to thehousing.

The insertion aid may comprise a detachable lower cover mechanicallycoupled to the detachable lower cap. As further used herein, the term“cover” may refer to an arbitrary element that completely or at least toa large extent closes an object. Specifically, the cover may be or maycomprise a shell, particularly a half-shell, surrounding the medicaldevice. The detachable lower cover may be configured such that a removalof the detachable lower cover removes the detachable lower cap. Theinsertion aid may further comprise at least one upper cover. The uppercover may be directly or indirectly coupled to one or both of theinsertion cannula or the detachable upper cap, such that a movement ofthe upper cover against the frame drives the insertion cannula. Theterms “lower cover” and “upper cover” may be considered as descriptionwithout specifying an order and without excluding a possibility thatseveral kinds of lower covers and upper covers may be applied. Theinsertion aid may further comprise at least one frame. The term “frame”may refer to an arbitrary element which may be configured to supportother components of a physical construction. The frame may bedisplaceable on the skin of the user and may at least partially surroundthe housing. The upper cover may be movable against the frame.

In a further aspect of the present invention, a method for assembling amedical device according to any embodiment as described above or asfurther described below is disclosed. The methods comprise the methodsteps as given in the independent claims and as listed as follows. Themethod steps may be performed in the given order. However, other ordersof the method steps are feasible. Further, one or more of the methodsteps may be performed in parallel and/or on a timely overlappingfashion. Further, one or more of the method steps may be performedrepeatedly. Further, additional method steps may be present which arenot listed.

The method for assembling the medical device comprises:

-   -   a) providing at least one part of the housing, the at least one        part of the housing comprising the sensor compartment with the        detachable upper cap and the detachable lower cap;    -   b) placing the analyte sensor at least partially into the sensor        compartment, wherein the analyte sensor and the at least one        part of the housing provided in step a) form an intermediate        product;    -   c) sterilizing the intermediate product; and    -   d) connecting the electronics unit to the intermediate product.

The housing may be manufactured by injection molding. During step b) atleast one further element may be placed at least partially into thesensor compartment. The at least one further element may be selectedfrom the group consisting of: an insertion cannula, a sealing element,particularly a septum. The method may further comprise operablyconnecting, specifically electronically connecting, the analyte sensorwith the electronics unit.

Step c) may be conducted by at least one sterilization process based onradiation, particularly ebeam sterilization. The method may furthercomprise at least one step of sterilizing the electronics unit,particularly by gas sterilization.

Specifically, the method may be performed such that step c) is performedbefore performing step d), in order to avoid exposing the electronicsunit to the radiation. Similarly, the sterilization of the electronicsunit may be performed after placing the electronics unit into theelectronics compartment or into the at least one part thereof, in astate in which the sensor compartment is sealed, such as by thedetachable upper cap and the detachable lower cap. Consequently, forsterilizing the electronics unit, a gas sterilization may be used, suchas by using ethylene oxide. Since the sensor compartment is sealed bythe upper cap and the lower cap, the gas used for gas sterilizing theelectronics unit may be prevented from entering the sensor compartmentand, thus, may be prevented from affecting the analyte sensor or atleast the insertable portion of the analyte sensor disposed therein.

By using this two-step sterilization, the specific requirements andsensitivities of the different components may be accounted for. Thus,generally, the electronics unit is sensitive against and may be damagedby high energy radiation, such as gamma rays or electron beams.Consequently, the radiation sterilization may be performed on theintermediate product, without the electronics unit being connected tothe analyte sensor, in order to sterilize the analyte sensor or at leastthe insertable portion of the analyte sensor. Contrarily, the analytesensor or typical sensor chemicals used therein in most cases aresensitive against and may be damaged by sterilizing gases such asethylene oxide. Consequently, the sterilization of the electronics unitconnected to the analyte sensor may be performed such that thesterilizing gas such as the ethylene oxide is prevented from interactingwith the insertable portion of the analyte sensor. Consequently, thesterilization processes may be optimized independently, without takingthe risk of destroying the electronics unit by radiation and withouttaking the risk of destroying the analyte sensor by sterilizing gas.

In a further aspect of the present invention, a method of using themedical device according to any embodiment as described above or asfurther described below is disclosed. The methods comprise the methodsteps as given in the independent claims and as listed as follows. Themethod steps may be performed in the given order. However, other ordersof the method steps are feasible. Further, one or more of the methodsteps may be performed in parallel and/or on a timely overlappingfashion. Further, one or more of the method steps may be performedrepeatedly. Further, additional method steps may be present which arenot listed.

The method of using a medical device comprises:

-   -   I. providing the medical device;    -   II. removing the detachable lower cap;    -   III. inserting the analyte sensor into the body tissue; and    -   IV. removing the detachable upper cap, thereby removing the        insertion cannula from the medical device.

The medical device may further comprise the at least one insertion aidcomprising the at least one upper cover and the detachable lower coveras described above. Thereby, the method of using a medical device mayfurther comprise:

-   -   i. removing the detachable lower cover, thereby removing the        detachable lower cap;    -   ii. inserting the analyte sensor into the body by applying an        insertion mechanism via the upper cover.

The housing and/or the interconnect device may comprise the at least oneadhesive surface, such as an adhesive surface which may optionally becovered by at least one protective foil, wherein, such as during step i.and/or during step ii., the protective foil may be removed.Specifically, the detachable lower cover may be removed by a rotatorymotion. However, other embodiments are feasible. The upper cover maycomprise at least one spring drive and before conducting step i. thespring drive may be tightened thereby securing parts of the insertionmechanism, wherein after conducting step II., the insertion cannula isretracted by at least one spring.

The proposed medical device, the method for assembling a medical deviceand the method of using a medical device provide many advantages overknown devices and methods.

Usually, common medical devices may initially comprise two components.The two components may form a final product after application of themedical device to the body tissue of the user. The analyte sensor maycommonly have to be connected to the electronics unit via the user. Thismay specifically lead to errors during application and thus to severeconsequences such as measurement errors. Therefore, in common medicaldevices, elaborate constructions may generally have to be realized tocircumvent error sources. The elaborate constructions may exemplarilycomprise sealings, electrical contacts or locking forces.

Specifically in case of analyte sensors which are electrochemicalsensors, electronic components may generally not be treatable via beamsterilization. However, electrochemical sensors themselves generally mayonly be treatable via beam sterilization so that a functionality of theelectrochemical sensor may be ensured.

Therefore, the medical device according to the present invention maycomprise a combination of a sterile compartment including the analytesensor and the electronics unit which may specifically be a single-useelectronics unit. The sterile compartment may be integrated into orattached to the electronics unit.

The user may receive an “all-in-one” medical device without a need forassembling the medical device. The medical device may further be robustand low-priced. An application of the medical device to the body tissueof the user may be conductible in a simple and intuitive manner.

Parts of the medical device may remain at the body tissue of the userafter using the medical device. These parts may stay at the body tissueduring a predetermined application period. A sterilization of theanalyte sensor and a subsequent assembling of the electronics unitduring assembling the medical device may be realized without opening thesealed compartment. Further, a compact and small construction as well asa simple assembling may be possible.

During using the medical device, the housing may be opened by the user.A protective foil of the adhesive element may be removed and thedetachable lower cap may be detached. The medical device may be mountedon the body tissue of the user and the analyte sensor may be insertedinto the body tissue. The insertion cannula may be removed from the bodytissue. Thereafter, the detachable upper cap may be detached from themedical device.

The septum may be an individual component or may be manufactured byinjection molding. The barbed hook may be configured to prevent a secondusage of the insertion cannula. The barbed hook may be an additionalcomponent or may be integrated as one component. The insertion cannulamay be a tube or a stamped-bent part. The insertion cannula may besealed by the septum.

Therefore, the insertion cannula may specifically have a roundcross-section. However, other embodiments such as a flat design arefeasible.

The insertion aid may comprise the upper cover. The upper cover may bepart of the primary packaging. Further, the user may use the upper coverfor using the medical device. The upper cover may be fixedly connectedto the detachable upper cap. The insertion aid may have the retractionmechanism configured to retract the insertion cannula automaticallyafter the insertion cannula has been inserted into the body tissue. Thedetachable lower cover of the insertion aid may be part of the primarypackaging. Further, the detachable lower cover may be fixedly connectedto the detachable lower cap. During opening of the detachable lowercover, the detachable lower cap may be opened at the same time and theadhesive surface may be exposed. The frame may protect the insertioncannula, specifically before using the medical device. The user may holdthe medical device onto the body tissue. The frame may require aninitial force such that the user may build up a force during manuallyinserting the insertion cannula and may insert quickly. The frame maytrigger a mechanism such that the insertion cannula may be withdrawnautomatically as soon as the frame is compressed. Specifically, themechanism may be a spring-pretensioned mechanism. The insertion aid mayprovide an easy handling for the user.

The detachable lower cover may comprise a basis which is fixedlyconnected to a lower part of the detachable lower cap, exemplarily via asnap connection, an adhesive bonding and/or a longitudinal guide ortransferring force. The basis may comprise gripping surfaces fordetaching the detachable lower cover. The basis may at the same time bea cover for the adhesive surface. This may lead to an extendedshelf-life of the adhesive surface. By detaching of the detachable lowercover, the detachable lower cap may be opened, the insertion cannula andthe analyte sensor may be exposed and the adhesive surface may beexposed at the same time.

The upper cover of the insertion aid may comprise the spring drive. Thespring drive may be configured to trigger the insertion of the insertioncannula. The spring drive may be tensioned during pressing theelectronics unit into the insertion aid. The insertion cannula may clickinto an element which may trigger a withdrawing of the insertion cannulaafter insertion.

The upper cover may comprise guiding elements such that a circulation ofthe electronics unit within the insertion aid is at least to a largeextent suppressed. Exemplarily, the electronics unit may have anon-round shape, there may be guiding rails in an external shape of theelectronics unit and/or there may be special structures such as nutswithin the electronics unit.

The insertion aid may be triggered via a release button. The medicaldevice may be shot on the body tissue. At a bottom dead center thespring drive may be released for withdrawing the insertion cannula. Theinsertion aid may be removed from the body tissue. The user mayoptionally detach the detachable upper cap with the insertion cannula byhand. Optionally, the user may tilt the insertion aid thereby detachingthe detachable upper cap.

A tensioning of the medical device may be realized via a rotationalmovement. Thereby, the housing may be turned on and may be hold up frombelow. This may exemplarily be realized by a suitable formed primarypackaging. Thereby, the primary packaging may be coupled with thedetachable lower cap. Exemplarily, the insertion aid may be configuredto conduct the rotational movement for detaching the detachable lowercap by itself. This may be realized as follows: During tensioning of themedical device, two mechanisms may be tensioned. A first mechanism mayrefer to a spring system for inserting the analyte sensor into the bodytissue as described above. A second mechanism may refer to therotational movement as described above. The electronics unit may befixed at a top dead center within the insertion aid. As soon as theelectronics unit may be fixed, there may be a rotational movement in acounter direction.

Alternatively, other mechanisms may be applied to remove the detachableupper cap from the electronics compartment such as a coupled mechanismwhich may be withdrawable in an easy manner, cutting a breaking pointwith a knife or turning off the detachable upper cap. The detachableupper cap does not need to be fixedly connected to the electronicscompartment. To facilitate assembling of the medical device and/or tofacilitate removing the detachable upper cap by the user, the couplemechanism may be applied. Exemplarily, a tube-in-tube-system may beapplied comprising a sealing with an elastic mass such as rubber,thermoplastic polymers, an epoxy or silicone.

By using a flexible interconnect device, such as a flexible printedcircuit board, the at least one electronic component may be applied to aflexible, bendable part and, consequently, may be in a less spacey stateas compared to the electronics unit with the analyte sensor insertedinto the body tissue and the electronics unit flatly resting on the skinof the user.

During the insertion process, when the whole medical device is pressedonto the skin and when the sensor is inserted into the body tissue, theskin may distort and bulge inwardly, at the insertion site. In case theskin is not held in place by a stiff device, such as a body mountincluding a plaster, the insertion depth may, thus, vary, depending onthe bulging of the skin. By deforming the electronics unit duringinsertion, such as by folding the flaps upwardly, a more constantinsertion depth may be achieved.

Further, the use of a flexible interconnect device such as a flexibleprinted circuit board significantly may increase the comfort of wearingthe medical device and the analyte sensor inserted into the body tissue.Additionally, a stiff body mount is more prone to losing contact withand detaching from the skin of the user. A flexible system, contrarily,may move with the movement of the skin and provides a lower surface formechanical influences. Consequently, the stability of the device isincreased as compared to conventional devices.

Thus, generally, during step VII. of the method of using the medicaldevice, the at least two portions of the interconnect device, such asthe at least two flaps, may be folded or bent upwardly. After insertion,the at least two portions may be folded back, in order to rest flatly onthe skin of the user. This foldable medical device generally may lead toa compact medical device which may easily be manufactured. The user mayobtain a completely manufactured continuous monitoring system withoutneed for further assembly, as compared to e.g. a system which requiresan establishment of electrical connections by the user, such as by usingone or more plugs. The risk of failure during application of the analytesensor thereby is greatly reduced. Further, the medical device may bedesigned as a compact system for insertion. Further, the robustness maybe increased, and the cost of the medical device may be reduced due to alowering of the number of parts required for the medical device.

Further, a part of the housing may remain on the body of the user afterinsertion. Thus, as outlined above, an intermediate component may remainon the skin of the user, after detaching the lower and upper cap andafter insertion of the analyte sensor.

The at least one electronic component may fully or partially beencapsulated. Thus, as outlined above, an encapsulation may even beprovided in a soft fashion, by using soft materials for encapsulatingthe at least one electronic component. Thus, the at least one electronichousing may fully or partially be made of at least one flexible ordeformable or soft material. As an example, rubber, silicone, athermoplastic polymer, or other soft materials may be used, whichfurther increases the comfort of wearing the medical device.

By using an insertion aid, such as an insertion aid comprising the atleast one housing and/or the at least one upper cap and/or the insertioncannula, the electronics unit may be designed in a small fashion duringinsertion, wherein, afterwards, by flapping down the portions of theinterconnect device, the electronics unit may be mounted to the skin ofthe user, e.g. without opening a sterile range. Consequently, a compactsystem and a simple mounting and insertion may be realized.

Summarizing, the following embodiments are potential embodiments of thepresent invention. Other embodiments, however, are feasible.

Embodiment 1: A medical device for detecting at least one analyte in abody fluid, the medical device comprising:

-   -   at least one analyte sensor having an insertable portion adapted        for at least partially being inserted into a body tissue of a        user,    -   at least one insertion cannula, wherein the analyte sensor at        least partially is placed inside the insertion cannula;    -   at least one housing, wherein the housing comprises at least one        sensor compartment, wherein the sensor compartment forms a        sealed compartment receiving at least the insertable portion of        the analyte sensor, wherein the sealed compartment comprises at        least one detachable upper cap and at least one detachable lower        cap, wherein the detachable lower cap is configured for        detachment before insertion, thereby opening the insertable        portion for insertion, wherein the insertion cannula is attached        to the detachable upper cap, wherein the detachable upper cap is        configured for detachment after insertion, thereby removing the        insertion cannula; and    -   at least one electronics unit, wherein the analyte sensor is        operably connected to the electronics unit, wherein the        electronics unit comprises at least one interconnect device with        at least one electronic component attached thereto, wherein the        interconnect device fully or partially surrounds the housing.

Embodiment 2: The medical device according to the preceding embodiment,wherein the interconnect device comprises a printed circuit board.

Embodiment 3: The medical device according to any one of the precedingembodiments, wherein the interconnect device comprises a flexibleprinted circuit board.

Embodiment 4: The medical device according to the preceding embodiment,wherein the flexible printed circuit board is fully or partially made ofpolyimide.

Embodiment 5: The medical device according to any one of the precedingembodiments, wherein the interconnect device comprises an upper side anda lower side, wherein the lower side comprises at least one adhesiveelement for attachment of the interconnect device to the skin of theuser.

Embodiment 6: The medical device according to any one of the precedingembodiments, wherein the interconnect device comprises a first portion,preferably a first flap, having the electronic component attachedthereto, and a second portion, preferably a second flap, having anelectrical energy reservoir, preferably a battery, attached thereto.

Embodiment 7: The medical device according to the preceding embodiment,wherein the first portion and the second portion each have anessentially circular shape.

Embodiment 8: The medical device according to any one of the twopreceding embodiments, wherein the interconnect device has the shape ofthe wings of a moth or butterfly.

Embodiment 9: The medical device according to any one of the threepreceding embodiments, wherein the first portion and the second portionare foldable, preferably in an upwardly or downwardly fashion towards anaxis of the housing.

Embodiment 10: The medical device according to any one of the precedingembodiments, wherein the interconnect device has an opening, wherein thehousing fully or partially penetrates the interconnect device throughthe opening.

Embodiment 11: The medical device according to the preceding embodiment,wherein the housing is attached to a rim of the opening of theinterconnect device.

Embodiment 12: The medical device according to any one of the precedingembodiments, wherein the detachable upper cap and the detachable lowercap are disposed on opposite sides of the interconnect device.

Embodiment 13: The medical device according to any one of the precedingembodiments, wherein the sensor compartment comprises at least oneintermediate component disposed in between the detachable upper cap andthe detachable lower cap.

Embodiment 14: The medical device according to the preceding embodiment,wherein the intermediate component comprises a sealing ring.

Embodiment 15: The medical device according to any one of the twopreceding embodiments, wherein the detachable upper cap and thedetachable lower cap are attached to one another, preferably by ascrewing mechanism, with the intermediate component located in betweenthe detachable upper cap and the detachable lower cap.

Embodiment 16: The medical device according to any one of the threepreceding embodiments, wherein the intermediate component comprises atleast one sealed opening, wherein the analyte sensor passes through thesealed opening.

Embodiment 17: The medical device according to the preceding embodiment,wherein the insertable portion of the analyte sensor at least partiallyis received in the sensor compartment, wherein an opposing end of theanalyte sensor is attached to the electronics unit.

Embodiment 18: The medical device according to any one of the fourpreceding embodiments, wherein the intermediate component is fully orpartially made of a deformable material, preferably of a flexible or anelastic material.

Embodiment 19: The medical device according to any one of the fivepreceding embodiments, wherein the interconnect device is connected tothe intermediate component.

Embodiment 20: The medical device according to the preceding embodiment,wherein the interconnect device at least partially surrounds theintermediate component.

Embodiment 21: The medical device according to any one of the twopreceding embodiments, wherein the intermediate component comprises aprotruding rim, wherein the interconnect device is connected to theprotruding rim.

Embodiment 22: The medical device according to any one of the precedingembodiments, wherein the insertion cannula is fixedly attached to thedetachable upper cap.

Embodiment 23: The medical device according to any one of the precedingembodiments, wherein the medical device further comprises at least oneseptum received in the sensor compartment, wherein the insertion cannulapasses through the septum, wherein the septum is configured for sealinga remainder of the sensor compartment after detachment of the detachableupper cap.

Embodiment 24: The medical device according to any one of the precedingembodiments, wherein the electronics unit contains a single electroniccomponent attached to the interconnect device, wherein the electroniccomponent is configured to control a measurement performed with theanalyte sensor.

Embodiment 25: The medical device according to the preceding embodiment,wherein the electronic component contains an application-specificintegrated circuit.

Embodiment 26: The medical device according to any one of the twopreceding embodiments, wherein the electronic component contains atleast one of a measurement device configured for performing anelectrochemical measurement with the analyte sensor.

Embodiment 27: Method for assembling a medical device according to anyone of the preceding embodiments, wherein the method comprises:

-   -   a) providing at least one part of the housing, the at least one        part of the housing comprising the sensor compartment with the        detachable upper cap and the detachable lower cap;    -   b) placing the analyte sensor at least partially into the sensor        compartment, wherein the analyte sensor and the at least one        part of the housing provided in step a) form an intermediate        product;    -   c) sterilizing the intermediate product; and    -   d) connecting the electronics unit to the intermediate product.

Embodiment 28: The method according to the preceding embodiment, whereinstep c) comprises a radiation sterilization.

Embodiment 29: The method according to any one of the two precedingembodiments, the method further comprising at least one step ofsterilizing the electronics unit.

Embodiment 30: The method according to the preceding embodiment, whereinthe step of sterilizing the electronics unit comprises a gassterilization.

Embodiment 31: Method of using the medical device according to any oneof the preceding embodiments referring to a medical device, the methodcomprising:

-   -   I. providing the medical device;    -   II. removing the detachable lower cap;    -   III. inserting the analyte sensor into the body tissue; and    -   IV. removing the detachable upper cap, thereby removing the        insertion cannula from the medical device.

SHORT DESCRIPTION OF THE FIGURES

Further details of the invention may be derived from the followingdisclosure of preferred embodiments. The features of the embodiments maybe realized in an isolated way or in any combination.

The invention is not restricted to the embodiments. The embodiments areschematically depicted in the figures. Identical reference numbers inthe figures refer to identical elements or functionally identicalelements or elements corresponding to each other with regard to theirfunctions.

In the figures:

FIG. 1 shows a cross-sectional view of a first embodiment of a medicaldevice;

FIG. 2 shows a top view of a second embodiment of a medical device;

FIG. 3 shows a perspective view of the second embodiment of the medicaldevice, with an electronic housing and an energy reservoir housingopened;

FIG. 4 shows the setup of FIG. 3 with an electronic component and anenergy reservoir removed;

FIG. 5 shows the embodiment of FIG. 2 with a first portion and a secondportion bent upwardly, in a perspective view;

FIG. 6 shows the setup of FIG. 5 in a side view, with the lower capremoved, with the insertion cannula before insertion;

FIG. 7 shows the setup of FIG. 6 during insertion; and

FIG. 8 shows the medical device after insertion (without the bodytissue).

DETAILED DESCRIPTION OF THE EMBODIMENTS

In FIG. 1 , a cross-sectional view of a first embodiment of a medicaldevice 110 for detecting at least one analyte in a body fluid is shown.The medical device 110 comprises an analyte sensor 112, which, as anexample, may be embodied as flexible analyte sensor and which preferablyis embodied as an electrochemical analyte sensor. The analyte sensor 112comprises an insertable portion 114 which is configured for insertioninto a body tissue of a user.

The medical device 110 further comprises an insertion cannula 116,which, as an example, may be embodied as a slotted insertion cannula116. Other types of insertion cannulae are feasible, too. The insertableportion 114 of the analyte sensor 112 is located inside the insertioncannula 116.

The medical device 110 further comprises a housing 118, enclosing asensor compartment 120. The sensor compartment 120 forms a sealedcompartment 122 which is sealed against an environment of the medicaldevice 110. The sealed compartment 122 receives the insertable portion114 of the analyte sensor 112 and, further, may receive the insertioncannula 116.

The housing 118, such as the sealed compartment 122, comprises adetachable upper cap 124 and a detachable lower cap 126. The detachableupper cap 124 and the detachable lower cap 126 may be connected to oneanother, such as by a screwing mechanism. Alternatively, however, thedetachable upper and lower cap 124, 126 may detachably be connected toother components of the housing 118.

The housing 118 may further comprise an intermediate component 128,which, preferably, may have the shape of a ring and/or which maysurround the insertion cannula 116 in a ring-shaped fashion. Theintermediate component 128 may comprise a sealed opening 130 throughwhich the analyte sensor 112 is guided out of the sealed compartment122, such that a connection portion 132 of the analyte sensor 112 islocated outside the sealed compartment 122. The intermediate component128, as an example, may fully or partially be made of a deformable orflexible material forming a sealing between the upper cap 124 and thelower cap 126. As an example, the intermediate component 128 may fullyor partially be made of an elastomeric material such as a rubber and/ora silicone.

The medical device 110 further comprises at least one electronics unit134. The electronics unit 134 comprises an interconnect device 136which, preferably, is fully or partially embodied as a flexible printedcircuit board 138. The interconnect device 136 may comprise, which isnot show in the figures, one or more conductive traces and/or one ormore contact portions such as contact pads. As an example, theconnection portion or contact portion 132 of the analyte sensor 112 mayelectrically be connected to one or more of the electrical traces and/orcontact pads of the interconnect device 136, in order to electricallycontact the analyte sensor 112. Thus, as an example, the intermediatecomponent 128 may comprise one or more protrusions 140 which simply maysupport the connection portion or contact portion 132 of the analytesensor 112 and/or which e.g. may press the connection portion or contactportion 132 of the analyte sensor 112 onto the interconnect device 136,such as onto one or more contact pads of the interconnect device 136and/or onto one or more conductive traces. The protrusion 140 maycomprise a rim 141 which fully or partially surrounds a region in whichthe analyte sensor 112 is electrically connected to the interconnectdevice 136. Further, a soldering and/or a conductive adhesive may beused for electrically connecting the analyte sensor 112 with theinterconnect device 136.

The electronics unit 134 further comprises at least one electroniccomponent 142 which may directly or indirectly be applied to theinterconnect device 136. As will be outlined in further detail below,the at least one electronic component 142 may fully or partially beencapsulated, such as by one or more electronic housings 144.

The interconnect device 136 may comprise at least one adhesive surface.Thus, as an example, the medical device 110, on a side of theinterconnect device 136 facing a skin of the user, also referred to as alower side 146, may comprise at least one adhesive element 148 and/or atleast one adhesive surface, such as a plaster. On the lower side 146,the plaster may comprise at least one removable liner which may beremoved before adhesion to the skin of the user.

For manufacturing the medical device 110 as shown in FIG. 1 , firstly,the housing 118 with the insertion cannula 116 and the analyte sensor112 at least partially disposed therein may be provided. Further, theinterconnect device 136 may be provided and, at this stage or at a laterstage, the analyte sensor 112 may operably be connected to theinterconnect device 136 and/or to an electronic component 142 disposedthereon. Preferably before providing an electronic component of theelectronics unit 134, the analyte sensor 112 may be sterilized, such asby radiation sterilization, e.g. by electron beam sterilization.Afterwards, the at least one electronic component 112 may be applied,such as by applying the at least one electronic component 142 to theinterconnect device 136. At this stage, preferably after sealing thehousing 118, a further step of sterilization may be applied, in order tosterilize the electronics unit 134. For this purpose, a method ofsterilization may be used which is not compatible with the insertableportion 114 of the analyte sensor 112, such as by using a gassterilization. The sterilizing gas, however, due to the sealingproperties of the housing 118 and, specifically, the sealed compartment122, may not reach the insertable portion 114 of the analyte sensor 112.Thus, the at least one electronic component 142 and the insertableportion 114 may be sterilized independently, without detrimentalinfluences.

In FIGS. 2 to 8 , a second embodiment of the medical device 110 isshown, which is widely similar to the embodiment shown in FIG. 1 ,except for minor differences which will be explained in further detailbelow. Therein, different views and different configurations of theembodiment are shown. FIG. 2 shows a top view, FIGS. 3 and 4 showperspective partial views, FIGS. 5, 6 and 7 show a folded configuration,and FIG. 8 shows a configuration with the upper and lower caps 124, 126and the insertion cannula 116 removed and with the electronics unit 134resting on a skin of a user (not shown), with the insertable portion 114of the analyte sensor 112 protruding into a body tissue of the user.These different views and configurations of the second embodiment of thepresent invention, in the following, will be explained in conjunction.For most components and reference numbers, reference may be made to thedescription of FIG. 1 above.

Thus, the medical device 110 widely corresponds to the setup shown inFIG. 1 . Again, an interconnect device 136 is provided, which may beembodied as a flexible printed circuit board 138. The interconnectdevice 136, however, in this embodiment, comprises a first portion 150,also referred to as a first flap, as well as a second portion 152, alsoreferred to as a second flap. The first and second portions, asspecifically shown in FIG. 2 , preferably may have a circular shape.However, other shapes are feasible. The circular shape, however, mayincrease the comfort of wearing. The interconnect device 136 may furthercomprise a central portion 154 which connects the interconnect device136 with the housing 118, such as, as can be seen in FIG. 3 , with theintermediate component 128 of the housing 118. The central portion 154of the interconnect device 136 may comprise an opening 156 for receivingthe housing 118. The interconnect device 136 may directly or indirectlybe attached to the intermediate component 128 of the housing 118, suchas by using a protruding rim of the intermediate component 128 or thelike.

As opposed to the setup shown in FIG. 1 , the embodiment shown in FIGS.2 to 8 shows an alternative connection between the analyte sensor 112and the electronics unit 134. Thus, in each embodiment, the analytesensor 112 may electrically be connected to the electronic component 142of the electronics unit 134, as shown e.g. in FIG. 3 , and/or to theinterconnect device 136, as e.g. shown in the embodiment of FIG. 1 . Acombination of both embodiments, however, is feasible.

The embodiment shown in FIGS. 2 to 8 further shows an option in whichthe electronics unit 134, besides the at least one electronic component142, comprises at least one electrical energy reservoir 158, such as abattery or the like. The at least one electronic component 142 may bedisposed directly or indirectly on the first portion 150 or first flap,whereas the at least one electrical energy reservoir 158 may directly orindirectly be disposed on the second portion 152, such as the secondflap. The electrical energy reservoir 158 may be electrically connectedto the electric component 142 via at least one electrical trace disposedon and/or in the interconnect device 136, which is not shown in thefigures.

As outlined above, the at least one electronic component 142 and/or theat least one electrical energy reservoir 158 may directly or indirectlybe connected to the interconnect device 136. Specifically, as shown inthe embodiment of FIGS. 2 to 8 , the electronic component 142 and/or theelectrical energy reservoir 158 may fully or partially be surrounded byat least one housing and/or encapsulation. Thus, in the embodiment shownin FIGS. 2 to 8 , the electronic component 142 is fully or partiallyencapsulated by an electronic housing 160 having a lower electronichousing component 162 attached to the interconnect device 136 with areceptacle 162 therein, for receiving the electronic component 142.Inside the receptacle 164, one or more contact pads and/or one or moreelectrical tracers may be provided, in order to connect the electroniccomponent 142 with the interconnect device 136. After placement of theelectronic component 142 and after connection of the analyte sensor 112to the electronic component 142, an upper electronic housing component166 may be applied, in order to cover the electronic component 142, ascan be seen when comparing the setup of FIGS. 3 and 5 . However, otherencapsulation techniques may be used, such as by using a casting, e.g.by using a rubber, a mold or another sealing for encapsulating theelectronic component 142.

Similarly, the electrical energy reservoir 158 may fully or partially beencapsulated. Thus, as can be seen e.g. in FIGS. 3 and 4 , theelectronics unit 134 may comprise an energy reservoir housing 168, e.g.with a lower energy reservoir housing component 170 with a receptacle172 therein, which may directly or indirectly be attached to theinterconnect device 136, and, optionally, an upper energy reservoirhousing component 174. The housings 160, 168 may fully or partially bemade of rigid materials or may fully or partially be made of deformableor soft materials. Thus, again, as an example, the upper energyreservoir housing component 174 may also fully or partially be made of adeformable material, such as a moldable or castable material.

As outlined above, the interconnect device 136 preferably is fully orpartially be made of a flexible or deformable material. Thus, as anexample, a flexible printed circuit board 138 may be used. This allowsfor a handling, in which the interconnect device 136, during insertion,has a different configuration as compared to the configuration later on,with the analyte sensor 112 inserted. As an example, the foldable flaps150, 152 may be folded upwardly, as shown e.g. in FIGS. 5 to 7 . Thus,firstly, the flaps 150, 152 may be bent upwardly, and the lower cap 126may be removed, as shown in FIG. 6 . The insertion cannula 116 maypierce the skin 176 of the user, as shown in FIG. 6 . An adhesivesurface 178 on a lower side 146 of the medical device 110 may, firstly,get in contact with the skin 176 in the range of the central portion154, as shown e.g. in FIG. 7 . Afterwards, after insertion, the portions150, 152 may be folded back in a horizontal position, resting on theskin 176, and adhering to the skin 176. Further, the detachable uppercap 124 with the insertion cannula 116 may be removed, therebytransforming the configuration from FIG. 7 into the configuration shownin FIG. 8 , with the sensor 112 with its insertable portion 114 insertedinto the body tissue and with the detachable upper cap 124 and thecannula 116 removed.

LIST OF REFERENCE NUMBERS

-   -   110 medical device    -   112 analyte sensor    -   114 insertable portion    -   116 insertion cannula    -   118 housing    -   120 sensor compartment    -   122 sealed compartment    -   124 detachable upper cap    -   126 detachable lower cap    -   128 intermediate component    -   130 sealed opening    -   132 connection portion    -   134 electronics unit    -   136 interconnect device    -   138 flexible printed circuit board    -   140 protrusion    -   141 rim    -   142 electronic component    -   144 electronic housing    -   146 lower side    -   148 adhesive element    -   150 first portion    -   152 second portion    -   154 central portion    -   156 opening    -   158 electrical energy reservoir    -   160 electronic housing    -   162 loser electronic housing component    -   164 receptacle    -   166 upper electronic housing component    -   168 energy reservoir housing    -   170 lower energy reservoir housing component    -   172 receptacle    -   174 upper energy reservoir housing component    -   176 skin    -   178 adhesive surface

1. An assembly of components for mounting an analyte sensor and ahousing on a user, the assembly comprising: a housing defining a sealedsensor compartment, the housing comprising an upper cap, a lower cap,and an intermediate component, the intermediate component being attachedto the upper cap and to the lower cap, the housing comprising anelectronics compartment comprising an electronics unit; an analytesensor comprising an insertable portion adapted for at least partiallybeing inserted into the user's body tissue; and a cannula attached tothe upper cap, the insertable portion of the analyte sensor beingreceived inside the cannula, the intermediate component defining asealed opening, and the analyte sensor extending from the sealed sensorcompartment through the sealed opening to the electronics compartment,the analyte sensor being operably connected to the electronics unit, theintermediate component defining a cannula aperture extending from anupper surface opening to a lower surface opening, the lower cap beingconfigured to seal with the lower surface opening of the intermediatecomponent, the lower cap comprising an interior volume receiving thecannula and the insertable portion of the analyte sensor, the upper capbeing configured to seal with the upper surface opening of theintermediate component, the lower cap being configured for removal fromthe intermediate component prior to insertion of the analyte sensor, theupper cap and the cannula being configured for removal from theintermediate component after insertion of the analyte sensor, thecannula extending downwardly from the upper cap, through the cannulaaperture, and beyond the lower surface opening, the insertable portionof the analyte sensor extending downwardly within the cannula and beyondthe lower surface opening, and the lower cap extending downwardly fromthe intermediate component, and the housing having a sealed condition,prior to insertion of the analyte sensor, in which the upper cap and thelower cap form with the intermediate component the sealed sensorcompartment surrounding and sealing the cannula and the insertableportion of the analyte sensor from the environment.
 2. The assembly ofclaim 1 in which, prior to insertion of the analyte sensor, the assemblyis in the sealed condition in which: the upper cap is sealing the uppersurface opening of the intermediate component, the lower cap is sealingthe lower surface opening of the intermediate component, the cannula isin a non-insertion position outside the user's skin, and the electronicscompartment is in a non-contact position outside the user's skin.
 3. Theassembly of claim 2 in which, in the sealed condition, the upper cap andthe lower cap are attached to each other.
 4. The assembly of claim 3 inwhich the upper cap and the lower cap are attached to each other by ascrewing mechanism.
 5. The assembly of claim 1 in which the assemblyfurther comprises a lower cover attached to the lower cap.
 6. Theassembly of claim 5 in which the lower cover is configured such thatremoval of the lower cover removes the lower cap.
 7. The assembly ofclaim 6 in which the upper cap and the lower caps are attached to eachother by a screwing mechanism.
 8. The assembly of claim 5 in which theassembly comprises an upper cover attached to the lower cover.
 9. Theassembly of claim 8 in which the lower cover is configured to bedetached from the upper cover by a rotary motion.
 10. The assembly ofclaim 8 in which the upper cap and the lower cap are attached to eachother by a screwing mechanism.
 11. The assembly of claim 10 in which thelower cover is configured to be detached from the upper cover by arotary motion.
 12. The assembly of claim 8 in which the upper cover andthe lower cover together surround the electronics compartment, thesealed sensor compartment, the cannula, and the analyte sensor.
 13. Theassembly of claim 1 in which the assembly, prior to insertion of theanalyte sensor, is configured for detachment of the lower cap, therebyopening the sealed sensor compartment and exposing the cannula.
 14. Theassembly of claim 1 in which the assembly has an opened condition inwhich: the lower cap is detached from the upper cap and removed fromsealing the lower surface opening of the intermediate component, thecannula is in a non-insertion position, and the electronics compartmentis in a non-contact position.
 15. The assembly of claim 13 in which theassembly further comprises a frame configured to support the assembly onthe user's skin during insertion of the analyte sensor, the assemblyhaving a mounting condition in which: the lower cap is removed fromsealing the lower surface opening of the intermediate component, thecannula is in the non-insertion position, and the electronicscompartment is in the non-contact position.
 16. The assembly of claim 15in which, in the mounting condition, the upper cap, the cannula, theanalyte sensor, and the electronics compartment are recessed in theframe.
 17. The assembly of claim 15 in which, in the mounting condition,the cannula and the upper cap are configured to move together relativeto the frame from the non-insertion position to an insertion position toinsert the cannula into the user's body tissue, and the electronicscompartment is configured to move relative to the frame from thenoncontact position to a contact position to mount the electronicscompartment on the user's skin.
 18. The assembly of claim 17 in whichthe cannula, the analyte sensor, and the upper cap are configured tomove together relative to the frame from the non-insertion position tothe insertion position as the electronics compartment moves relative tothe frame from the non-contact position to the contact position.
 19. Theassembly of claim 18 in which the assembly further comprises an uppercover directly or indirectly coupled to one or both of the cannula orthe upper cap, the upper cover, the upper cap, the cannula, and theanalyte sensor moving together from the non-insertion position to theinsertion position, and the electronics compartment moving with theupper cover from the non-contact position to the contact position. 20.The assembly of claim 19 in which the upper cover, the upper cap, thecannula, and the analyte sensor are configured to move together from thenon-insertion position to the insertion position relative to the frame.21. The assembly of claim 19 in which the electronics compartment movesfrom the noncontact position to the contact position relative to theframe.
 22. The assembly of claim 18 in which the assembly is in aninsertion condition in which: the lower cap is removed from the lowersurface opening of the intermediate component, the cannula is in theinsertion position extending into the user's body tissue, and theelectronics compartment is moved from the non-contact position to thecontact position and is contacting the user's skin.
 23. The assembly ofclaim 22 and further comprising an adhesive configured to adhere theelectronics compartment to the user's skin.
 24. The assembly of claim 23in which, following analyte sensor insertion, the upper cap and thecannula are configured to be withdrawn from the user's body tissue to awithdrawn position.
 25. The assembly of claim 24 in which the upper capand the cannula are configured to be withdrawn together into the uppercover.
 26. The assembly of claim 1 in which the assembly is in awithdrawn condition, following insertion of the analyte sensor, inwhich: the upper cap is removed from sealing the upper surface of theintermediate component, the cannula is in a withdrawn position withdrawnfrom the user's body tissue and into the upper cover, the analyte sensoris inserted into the user's body tissue, and the electronics compartmentis on the user's skin.
 27. The assembly of claim 1 in which the assemblyis in a mounted condition in which the lower cap is removed from sealingthe lower surface opening of the intermediate component, the upper capand the cannula are separated from the intermediate component, theinsertable portion of the analyte sensor is inserted into the user'sbody tissue, and the electronics compartment is on the user's skin. 28.An analyte monitoring system comprising: an assembly according to claim1, the electronics unit comprising an electronic component configuredfor performing a measurement with the analyte sensor, a device forrecording sensor signals, a device for storing measurement signals ormeasurement data, a transmitter for transmitting sensor signals and/ormeasurement data, and an energy source; and a second device, thetransmitter transmitting the sensor signals and/or measurement data tothe second device.
 29. A method for mounting an analyte sensor and anelectronics compartment on a user using an assembly according to claim1, the assembly further comprising an insertion aid comprising a framedisplaceable on the user's skin to support the analyte sensor and theintermediate component during insertion of the cannula and the analytesensor, the upper cap, the cannula and the electronics compartment beingconfigured to move together in the direction of insertion to insert thecannula and the insertable portion of the analyte sensor into the user'sbody tissue, and to mount the electronics compartment on the user'sskin, the method comprising: removing the lower cap from theintermediate component; displacing the frame on the user's skin;advancing the upper cap, the cannula and the intermediate component inthe direction of insertion to insert the cannula and the insertableportion of the analyte sensor into the user's body tissue, and to mountthe electronics compartment on the user's skin, the upper cap, thecannula, and the electronics compartment advancing in the direction ofinsertion relative to the frame; and withdrawing the upper cap and thecannula from the user's body tissue, leaving the analyte sensor insertedinto the user's body tissue and the electronics compartment mounted onthe user's skin.
 30. A mounting assembly for mounting an analyte sensorand an electronics compartment on a user, the analyte sensor includingan insertable portion adapted for at least partially being inserted intothe user's body tissue, the analyte sensor being configured to bemounted with the insertable portion extending through the user's skin,the housing comprising an electronics compartment at least partiallyreceiving an electronics unit operably connected to the analyte sensor,the housing further comprising an intermediate component comprising anupper surface including an upper surface opening and a lower surfaceincluding a lower surface opening, the intermediate component defining acannula aperture extending from the upper surface opening to the lowersurface opening, and the housing being configured to be mounted on theuser's skin, the mounting assembly comprising: a lower cap configured toseal with the lower surface opening of the intermediate component, thelower cap being configured for removal from the intermediate componentprior to insertion of the analyte sensor; an upper cap configured toseal with the upper surface opening of the intermediate component; and acannula, the intermediate component, the lower cap, and the upper capbeing configured to form a sealed sensor compartment, the cannula andthe insertable portion of the analyte sensor being sealed within thesealed sensor compartment, the cannula being attached to the upper capand extending downwardly within the sealed sensor compartment from theupper cap, through the cannula aperture, and beyond the lower surfaceopening, the analyte sensor being at least partially received in thecannula and the insertable portion of the analyte sensor extendingdownwardly within the cannula, from the upper cap, through the cannulaaperture, and beyond the lower surface opening, the lower cap extendingdownwardly from the lower surface of the intermediate component andcomprising an interior volume receiving the cannula and the insertableportion of the analyte sensor, the sealed sensor compartment beingconnected to the electronics compartment via a sealed opening, theanalyte sensor extending through the sealed opening from the sealedsensor compartment to the electronics compartment, and the upper cap andcannula being configured for removal from the intermediate componentafter insertion of the analyte sensor.